POLICY
Reportable incidents and certain IRB determinations will be promptly reported to appropriate authorities and agencies.
Key Terms
Continuing Noncompliance: A repeated pattern, act, or omission to act that suggests a future likelihood of reoccurrence of the noncompliance.
Serious Noncompliance: An act or omission to act that has the potential to increase a physical, psychological, safety, or privacy risk to research participants.
Suspension of IRB approval: An action initiated by the IRB to temporarily stop the research study pending future action by the IRB or by the Principal Investigator or his/her study personnel.
Termination of IRB approval: An action initiated by the IRB to permanently stop the research study.
Unanticipated problem involving risk to participants or others is a problem that is unanticipated or unexpected, related to the research and places subjects or others at a greater risk of harm than was previously known or recognized.
PROCEDURE
Reportable Incidents: The Institutional Official or designee will report the following IRB determinations:
- IRB determination of unanticipated problems involving risks to subjects or others;
- IRB determination of serious or continuing noncompliance; and
- Any suspension or termination of IRB approval.
Report Recipients: IRB Director or designee will report incidents to the following entities as applicable:
- Institutional Official (IO):
- IO for UTHealth Houston for all research under IRB jurisdiction.
- Memorial Hermann Health System research office for research conducted by Memorial Hermann staff or in Memorial Hermann facilities.
- Harris Health System research office for research conducted in Harris Health facilities.
- OHRP for all nonexempt human subjects research that is:
- conducted or supported by HHS;
- conducted or supported by any non-HHS federal department or agency that has adopted the Common Rule and is covered by a Federalwide Assurance (FWA) determined to be appropriate for such research; or
- covered by an FWA, regardless of funding source.
- Sponsor, if applicable including federal agencies like Department of Defense, Department of Education etc.
- FDA for applicable clinical investigations.
Information Included in The Report:
- Name of the institution conducting the research;
- Title of the research project and/or grant proposal in which the problem occurred;
- Name of the Principal Investigator on the protocol;
- Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
- A detailed description of the problem; and
- Actions the institution is taking or plans to take to address the problem.
Reporting Procedure
The IRB director or designee will prepare the report. The IRB director or designee may solicit guidance from the Executive Chairperson or Chairperson of the IRB that reviewed the protocol to prepare this report. The report may be shared with:
- Office of Legal Affairs and Institutional Compliance;
- Chair of the Principal Investigator’s department;
- Dean of the school of the Principal Investigator, staff or student;
- Office of Sponsored Projects Administration for research that receives funding by grant or contract;
- Any other authority as deemed appropriate.
Time frame for reporting incidents – The IRB director or designee shall report all incidents within 30 days of the IRB decision. The IRB Director or designee may send an initial report, and indicate that a follow-up or final report will be submitted by a specific date, when an investigation has been completed or a corrective action plan has been implemented.
Reporting to AAHRPP: the IRB director will report to AAHRPP as soon as possible but within 48 hours after the University or any researcher becomes aware of:
- Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions Placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human research protections.
- Any litigation, arbitration, or settlements initiated related to human research protections.
- Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the University’s Human Research Protection Program.
Exception - When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, the IRB approval expires automatically. Such expiration of the IRB approval will not be reported to OHRP and IO as a suspension of IRB approval.
REFERENCES
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 56 Institutional Review Board
- OHRP Guidance on Reporting Incidents to OHRP
- Mandatory IRB Reporting: FDA Contacts
- Unanticipated Problems Involving Risks to Subjects or Others.
- Non compliance
- Suspensions and Terminations
If you find errors in this document, contact [email protected]
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Document Number: |
101-E01 |
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Document Name: |
Reporting |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Jan 2009 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
